Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder

Northern California Institute of Research and Education0 sites16 target enrollmentFebruary 2003

ConditionsChronic Posttraumatic Stress Disorder

InterventionsEscitalopram

DrugsEscitalopram

Overview

Phase: Not Applicable
Intervention: Escitalopram
Conditions: Chronic Posttraumatic Stress Disorder
Sponsor: Northern California Institute of Research and Education
Enrollment: 16
Primary Endpoint: The Clinician Administered PTSD Scale
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.

A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

December 2004

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Northern California Institute of Research and Education

Eligibility Criteria

Inclusion Criteria

•Current DSM-IV TR PTSD and a score \> 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.

Exclusion Criteria

•Lifetime history of bipolar or any psychiatric disorder with psychotic features.
•Prominent suicidal or homicidal ideation.
•History of alcohol abuse/dependence within the past 3 months.
•History of drug abuse/dependence within the past 6 months.
•Subjects who plan to start a new form of psychotherapy during the protocol.
•History of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function.
•History of myocardial infarction in the past year.
•Subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
•Use of Citalopram or Escitalopram within the past 6 months.